Description

Own quality engineering activities across the medical device product lifecycle.

This role is on-site.

Responsibilities

• Partner with R&D and Operations to support new product development and engineering projects.
• Develop and implement quality control measures and risk management plans, including AFMEA, DFMEA, and PFMEA.
• Execute the Non-Conformance Report (NCR) process and lead technical problem solving, failure analysis, and root cause determination.
• Write, review, and approve process and product validation protocols, equipment qualifications, and engineering change orders.
• Ensure design control requirements, including Design Trace Matrix and MDR compliance, are met during product transfer to manufacturing.

Required Skills

• 5+ years of Quality Management experience in the Medical Device industry.
• Deep knowledge of FDA, ISO 13485, and ISO 14971 regulations.
• Experience with Medical Device Regulatory Standards, including MDD and MDR.
• Proficiency in NC, CAPA, and audit processes.
• Technical expertise in Risk Management, Design Control, and statistical analysis (ANOVA, Gauge R&R, Six Sigma).
• Apply statistical tools to analyze data, determine sample sizes, and improve process capability through SPC and DOE.
• Strong understanding of medical equipment manufacturing processes and procedures.
• Ability to manage complex engineering projects using project management methodologies.
• Excellent English communication skills, both written and verbal.

Preferred Skills

• Strong problem-solving and technical presentation skills.

Key Skills

Education

Any Graduate